Single Versus Multiple Injections for Axillary Plexus Block

Overview

Patients will be randomized to one of two groups: 1. Multiple injection group: Axillary brachial plexus block with multiple injections, with the arm abducted, performed with the aid of ultrasound; 2. Single injection group: Axillary brachial plexus block with a single injection, with the arm placed behind the head and the elbow flexed, performed with the aid of ultrasound

Full Title of Study: “Single Versus Multiple Injections for Axillary Plexus Block: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 9, 2019

Detailed Description

The study will be proposed to all patients undergoing formarm or hand surgery under axillary brachial plexus block. Patients will be randomized to one of two groups The first group - multiple injection group – will receive an ultrasound-guided axillary brachial plexus block with the traditional technique, i.e. multiple injections of local anesthetic in proximity to the 4 nerfs that innervate the arm. The arm will be abducted during the block procedure. The second group – single injection group – will receive an ultrasound-guided axillary brachial plexus block with the arm placed behind the head and the elbow flexed. In this position the different nerfs group around the axillary artery where they will be blocked with a single injection of local anesthetic. All patients will receive the same type and amount of local anesthetic: 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %. The primary outcome measure is the time needed for the performance of the block. Secondary outcomes are: success rate of the block at 30 minutes after the injection, needling time, time to first analgesic request, postoperative opioid consumption, pain scores at 12 and 24 hours postoperatively, block-related complications, and patient satisfaction. These outcomes are further defined in the section below.

Interventions

  • Drug: Multiple injection local anesthetic
    • Multiple injection local anesthetic
  • Drug: Single injection local anesthetic
    • Single injection local anesthetic

Arms, Groups and Cohorts

  • Active Comparator: Multiple injection local anesthetic
    • Ultrasound guided axillary plexus block with multiple injections of local anesthetic
  • Experimental: Single injection local anesthetic
    • Ultrasound guided axillary plexus block with a single injection of local anesthetic

Clinical Trial Outcome Measures

Primary Measures

  • Performance time
    • Time Frame: 10 minutes
    • Time in minutes from ultrasound probe placement to end of local anesthetic injection

Secondary Measures

  • Needling time
    • Time Frame: 15 minutes
    • Time in seconds to complete the block
  • Time to first analgesic request
    • Time Frame: 24 hours
    • Time in minutes to first analgesic request postoperatively
  • Block-related complications
    • Time Frame: 24 hours
    • Infection, bleeding, neurological problems, pain during the 24 postoperative hours
  • Postoperative opioid consumption on postoperative day 1
    • Time Frame: 24 hours
    • intravenous morphine equivalent consumption during the 24 postoperative hours
  • Pain scores at 12 hours postoperatively
    • Time Frame: 12 hours
    • Measured on a visual analogue scale between 0 and 10 (0 = no pain, 10 = worst pain imaginable)
  • Pain scores on postoperative day 1
    • Time Frame: 24 hours
    • Measured on a visual analogue scale between 0 and 10 (0 = no pain, 10 = worst pain imaginable)
  • Patient satisfaction
    • Time Frame: 24 hours
    • Assessed by numerical rating scale on a scale between 0 (= completely dissatisfied) and 10 (= completely satisfied)

Participating in This Clinical Trial

Inclusion Criteria

  • Adult patients who undergo forearm or hand surgery under axillary brachial plexus block Exclusion Criteria:

  • History of allergic reaction to local anaesthetics – Peripheral neuropathy – Renal or hepatic insufficiency – Coagulation disorders

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hôpital du Valais
  • Collaborator
    • University of Lausanne Hospitals
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sina Grape, Dr – Hôpital du Valais
  • Overall Official(s)
    • Sina Grape, MD, Principal Investigator, Hôpital du Valais
    • Eric Albrecht, MD, Study Director, Lausanne University Hospital

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